Measuring and Reducing Excessive Infant Crying: A Randomized Trial Candidate: Christopher Greeley, MD, the youngest Helfer Awardee to date for clinical and advocacy achievements in child abuse prevention and a recipient of a $100K Clinical Investigator Award for outstanding participants in our MS Program in Clinical Research, is committed to becoming a leader in rigorous research to prevent child abuse. Our Chairman recently moved him to the Center for Clinical Research and Evidence Based Medicine. He is mentored by its director, Jon Tyson, MD, MPH, a K12 director and recipient of national awards for education, mentorship, and perinatal and pediatric health care research. The mentorship committee also includes a prominent child abuse pediatrician, a developmental psychologist, and a clinical psychologist, all federally funded investigators with special expertise for this K23 research. Study Background. Excessive infant crying (EIC), particularly at night, distresses parents and may precipitate child abuse. Our pilot indicates that EIC can be reliably quantitated in the home using dosimeters (to record decibel levels at different distances from the infant) and a watch-like actigraph (to record leg movement) in a manner acceptable to parents. We propose to fully validate this method and rigorously test a commonly used set of parental soothing techniques to reduce EIC (The Happiest Baby on the Block [Karp]). Hypotheses. The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, &depression assessed in the home by a masked nurse at 8 wks. Methods. Term singleton infants with EIC (>3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant &maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05;beta = 0.20;effect size =0.5 SD, power = .90). The education, mentoring, and research noted above will enhance the methods to assess &address EIC and prepare Dr. Greeley to become a productive and independent clinical investigator and leader in rigorously designed and conducted research to prevent child abuse. PUBLIC HEALTH RELEVANCE: Excessive infant crying (EIC) is likely to increase the risk of child abuse. We propose a randomized trial using an intervention based on recommendations of Karp. We will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.